化学药品标准物质定量分析方法研究进展

doi:10.19803/j.1672-8629.20230407

摘要/Abstract

摘要： 目的综述目前化学药品标准物质的定量分析方法,为药品质量监管、药物安全性评价、药品检验及研发机构的标准物质研制提供借鉴。方法对化学药品标准物质定量分析方法的基本原理、适用范围、影响因素等进行介绍,并对不同定量方法的利弊进行分析。结果和结论 药品标准物质是药品研发、质量检测、安全监测等过程中检验检测的物质基础,是保证药品质量和保障药品标准实施的关键,而化学药品标准物质是其中占比最大的一类,其量值的准确性至关重要。在对化学药品标准物质进行定量分析时,要充分考虑各方法的适用性,选择最合适的方法。

关键词: 化学药品, 标准物质, 定量分析方法, 药品检验, 基准方法, 安全性评价, 质量控制

Abstract: Objective To study the quantitative analysis methods for chemical reference substances, so as to offer evidence and suggestions for drug quality regulation, drug safety evaluation and drug testing and research institutes that performing the establishment of reference substances. Methods The basic principles, scope, and influencing factors of the cutting-edge quantitative analysis methods of chemical drug standard substances were introduced. The pros and cons between different methods were compared and stated. Results and Conclusion Pharmaceutical Reference substances are the material basis for drug development, quality control testing, safety monitoring and etc., which are crucial to the insurance of the drug quality and the implementation of pharmaceutical specifications. The largest category among Pharmaceutical Reference standards are chemical drug reference substances, which makes the accuracy of their value are of vital importance. The applicability of each method should be fully considered in order to choose the most appropriate method in quantitative analysis of the chemical reference substances.

Key words: chemical drugs, reference substances, quantitative analysis methods, drug testing, primary method, safety evaluation, quality control

中图分类号:

R917

谭丽媛, 蔡彤, 王岩. 化学药品标准物质定量分析方法研究进展[J]. 中国药物警戒, 2023, 20(11): 1209-1216.

TAN Liyuan, CAI Tong, WANG Yan. Research progress in quantitative analysis methods for chemical reference substances[J]. Chinese Journal of Pharmacovigilance, 2023, 20(11): 1209-1216.

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